FDA.reportPublic FDA data

Alogliptin

Product NDC
71610-661
11-digit product format
716100661
Labeler code
71610
Product ID
71610-661_7ecf7f4e-e65c-4dde-9db9-20a170a427c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA022271
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-08
Substance
ALOGLIPTIN BENZOATE
Active strength
12.5 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alogliptin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOGLIPTIN BENZOATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEEN99869SC
Rxcui1368034

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36db81cb-9c11-39e1-6a1a-715fc2caa47cProduct name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-661-09Alogliptin9000 in 1 BOTTLETABLET, FILM COATED90002
71610-661-18Alogliptin3000 in 1 BOTTLETABLET, FILM COATED30002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-661-09EA - Each71610-66176b7a100-36ab-44e1-9af6-d800afeb58c212022-11-07
71610-661-18EA - Each71610-661bf21a1a7-8585-44fa-af48-31180d64007512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-661ALOGLIPTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20221019_a05d6d17-79f9-4788-a4d5-467bca1a2d91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368034alogliptin 12.5 MG Oral TabletPSNa05d6d17-79f9-4788-a4d5-467bca1a2d912
1368034alogliptin 12.5 MG Oral TabletSCDa05d6d17-79f9-4788-a4d5-467bca1a2d912
1368034alogliptin 12.5 MG (as alogliptin benzoate 17 MG) Oral TabletSYa05d6d17-79f9-4788-a4d5-467bca1a2d912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-661-09716100661099000 TABLET, FILM COATED in 1 BOTTLE (71610-661-09) 2022-09-080000-00-00NoNoCurrent
71610-661-18716100661183000 TABLET, FILM COATED in 1 BOTTLE (71610-661-18) 2022-10-170000-00-00NoNoCurrent